Duns Number:194877072
Device Description: Labels that provide a distinct color change when exposed to the appropriate sterilization Labels that provide a distinct color change when exposed to the appropriate sterilization process
Catalog Number
DDL-010
Brand Name
DUAL DOT LABEL
Version/Model Number
DDL-010
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JOJ
Product Code Name
Indicator, physical/chemical sterilization process
Public Device Record Key
565a84d3-6e2f-4071-9c19-1dd1fb883630
Public Version Date
February 19, 2021
Public Version Number
3
DI Record Publish Date
November 15, 2016
Package DI Number
50732224730719
Quantity per Package
10
Contains DI Package
10732224730711
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 26 |